Condition category
Nutritional, Metabolic, Endocrine
Date applied
19/01/2009
Date assigned
06/03/2009
Last edited
20/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kate Jolly

ORCID ID

Contact details

Unit of Public Health
Epidemiology and Biostatistics
Public Health Building
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 7552
c.b.jolly@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 4

Study information

Scientific title

Evaluation of weight reduction programmes in the "Lighten Up" service in South Birmingham primary care trust (PCT): a randomised controlled trial

Acronym

Lighten Up

Study hypothesis

The weight loss programmes (Weight Watchers®, Slimming World, Rosemary Conley, NHS Size Down, pharmacy and general practice provision) will each achieve significantly greater weight loss at 3 months follow-up than the comparison group of exercise at a leisure centre. There will be no differences between the weight loss services in weight loss at 3 months.

Ethics approval

South Birmingham Research Ethics Committee, approved on 19/12/2008 (ref: 08/H1207/331)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Obesity

Intervention

Participants will be allocated to one of the following eight arms:
1. Commercial weight loss programme: Weight Watchers
2. Commercial weight loss programme: Slimming World
3. Commercial weight loss programme: Rosemary Conley
4. Size Down (NHS community-based group programme)
5. Pharmacy-led obesity services
6. General practice service
7. Choice of intervention (1 to 6 above)
8. Comparator: Exercise advice + membership to leisure centre (Participants in this group will not be provided with any specific exercise programme)

Total duration of interventions: 12 weeks

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Weight at 3 months follow-up

Secondary outcome measures

1. Weight loss at 1 year
2. Self-reported physical activity using the International Physical Activity Questionnaire-Short version (IPAQ-Short) at 3 and 12 months
3. Percentage weight loss at 3 months and 1 year

Overall trial start date

26/01/2009

Overall trial end date

03/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged at least 18 years, both males and females
2. Body mass index greater than or equal to 30 (based on data recorded via NHS Quality and Outcomes Framework [QoF])
3. Identified by GP as medically competent to enter the programme evaluation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

740

Participant exclusion criteria

1. Unable to understand English
2. Women who are known to be pregnant
3. Not willing to be randomised

Recruitment start date

26/01/2009

Recruitment end date

03/01/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Unit of Public Health, Epidemiology and Biostatistics
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

NHS South Birmingham (UK)

Sponsor details

c/o Dr Jim O'Brien
Head of Clinical Governance
8th Floor
Triplex House
Eckersall Road
Kings Norton
Birmingham
B38 8SS
United Kingdom

Sponsor type

Government

Website

http://www.southbirminghampct.nhs.uk/

Funders

Funder type

Government

Funder name

NHS South Birmingham (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22053315

Publication citations

  1. Results

    Jolly K, Lewis A, Beach J, Denley J, Adab P, Deeks JJ, Daley A, Aveyard P, Comparison of range of commercial or primary care led weight reduction programmes with minimal intervention control for weight loss in obesity: lighten Up randomised controlled trial., BMJ, 2011, 343, d6500.

Additional files

Editorial Notes